SEGLENTIS

CELECOXIB AND TRAMADOL HYDROCHLORIDE

Manufacturer: Kowa Pharmaceuticals America, Inc.

Score: 144.0

Quick Summary

SEGLENTIS is a co-crystal tablet containing tramadol hydrochloride and celecoxib, used for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It has a boxed warning for serious and life-threatening risks, including addiction, abuse, and misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. The recommended dosage is 2 tablets every 12 hours as needed for pain, not to exceed 4 tablets over 24 hours. Special population considerations include use in pregnancy, pediatric use, geriatric use, and patients with certain medical conditions.

Key Clinical Findings and Indications

Management of acute pain in adults
Severe enough to require an opioid analgesic
Alternative treatments are inadequate

Important Safety Information

Warning

SEGLENTIS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Contraindications

All patients younger than 12 years of age
Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
Significant respiratory depression
In the setting of coronary artery bypass graft (CABG) surgery
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Previous hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to tramadol, opioids, celecoxib, sulfonamides, or any other component of the drug product
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

Adverse Reactions

Nausea
Vomiting
Dizziness
Headache
Somnolence

Dosing Recommendations

General Guidance

Do not exceed the recommended dose of SEGLENTIS. Do not co-administer SEGLENTIS with other tramadol or celecoxib containing products.

Acute pain

Adult Dose

2 tablets every 12 hours as needed for pain, not to exceed 4 tablets over 24 hours

Pediatric Dose

Special Population Considerations

Pregnancy

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome
Use of NSAIDs, including SEGLENTIS, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

Nursing Mothers

Pediatric Use

SEGLENTIS is contraindicated for all children younger than age 12 years of age
SEGLENTIS is contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy

Geriatric Use

No dose adjustments are required for elderly patients
Frequently reevaluate the patient for signs of central nervous system and respiratory depression

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